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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP BAND SYSTEM; ADJUSTABLE GASTRIC BAND
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RESHAPE LIFESCIENCES LAP BAND SYSTEM; ADJUSTABLE GASTRIC BAND Back to Search Results
Model Number C-20365
Device Problems Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2020
Event Type  malfunction  
Event Description
Gastric band tubing cuff fractured at level of band port.Tubing and cuff had also separated and were individually retrieved from abdominal cavity.Patient attended the clinic for a gastric band adjustment.A volume test was carried out and the gastric band was found to be empty.Previous notes indicated a fluid level of 7.5 ml.
 
Manufacturer Narrative
D4 model number to c-20365 and d4 catalog number to c-20365.No investigation was able to be performed on the product.The lot history search showed the product was manufactured to specification.Unable to determine root cause.A potential root cause was not determined.
 
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Brand Name
LAP BAND SYSTEM
Type of Device
ADJUSTABLE GASTRIC BAND
Manufacturer (Section D)
RESHAPE LIFESCIENCES
1001 calle amanecer
san clemente CA 92673
MDR Report Key11385916
MDR Text Key239129681
Report Number3013508647-2021-00002
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
PMA/PMN Number
P000008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/16/2020
Device Model NumberC-20365
Device Catalogue NumberC-20365
Device Lot NumberAF01694
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
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